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EurOK Protocol - Safety in Orthokeratology

This document outlines the steps and recommendations for developing an evidence-based orthokeratology protocol, including summarizing clinical evidence on efficacy and harms, weighing benefits vs risks, and documenting the process. It provides guidelines for orthokeratology practice including requirements for education, instrumentation, fitting protocol, patient education, follow-up care, lens care, and informed consent. The European Academy of Orthokeratology aims to establish standards for orthokeratology practice through these protocols and recommendations.

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89 views18 pages

EurOK Protocol - Safety in Orthokeratology

This document outlines the steps and recommendations for developing an evidence-based orthokeratology protocol, including summarizing clinical evidence on efficacy and harms, weighing benefits vs risks, and documenting the process. It provides guidelines for orthokeratology practice including requirements for education, instrumentation, fitting protocol, patient education, follow-up care, lens care, and informed consent. The European Academy of Orthokeratology aims to establish standards for orthokeratology practice through these protocols and recommendations.

Uploaded by

julzcat
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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EurOK

Protocol & Recommendations


Marino Formenti, O.D., FIAO!

Steps in developing

Evidence Based Orthokeratology Protocol

Orthokeratology as a strategy for myopia control!

Develop summary of evidence!

clinical efficacy (potential benefits)!

Potential harms!

Weigh benefits versus harms of the procedure!

Develop findings and recommendation statements!

Document all aspects of the process!

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

http://www.eurok.eu/content/references!

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

http://www.ncbi.nlm.nih.gov/pubmed/23892491

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

Review of Research Evidence


Strength of evidence rating!
LEVEL!

A!

B!

C!

D!

EVIDENCE!

QUALITY!

Strong research based evidence

multiple relevant
high quality studies

Moderate research based evidence

One relevant
high quality study

Limited research based evidence

One adequate study


somewhat relevant

Panel opinion

based on information not


meeting criteria for A-C

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

Practice of Orthokeratology
Pre-Requirements!
Fitting Practice!
Reception of Lenses!
Delivery of Lenses!
Follow/up procedures!
E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

Essential requirements for the


Practice of Orthokeratology
Education and C.E.!

Inexperience is no defence in terms of negligence!

Comprehensive knowledge of the underlying


Science of the Orthokeratology Process
Clinical Update is a MUST

Attendance of a Ortho-K course is firmly recommended.


Course would have to be given by a Professional Organization with
Orthokeratology in its mission (IAO or continental Section)
Industrial and/or commercial education only cannot be accepted
Danger of obsolete or outdated knowledge
Continuing Education: Congresses, workshops, Journals

Minimum Clinical Instrumentation


& Procedures!
Topographer
Biomicroscopy/Slit lamp
Fluoroscopy

Mandatory for corneal shape evaluation and fitting diagnosis


Mandatory for anterior segment inspection and diagnosis
Mandatory for corneal integrity evaluation and diagnosis

E u r o p e a n

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O r t h o k e r a t o l o g y!

Essential requirements for the


Practice of Orthokeratology
Ortho-k Lenses
Trial Lens Set!
Orthokeratology lenses

Trial lens vs Empirical fitting

CE marking is a must in Europe!


Highest DK. Low and Medium DK are NOT suitable for Ortho-K
Minimal O2 permeability = DK 87
If practitioner chooses to:
send the ocular data to the manufacturer
design the lens using a software
The first lens ordered for the patient will be a trial lens

Protocol & Recommendations!

Orthokeratology Protocol
Professional Insurance

EurOK Member is strongly recommended to practice in accordance with EurOKs Protocol


EurOK Protocol & Recommendations are visible on the Website by interested persons
EurOKs Member is strongly recommended to have a professional insurance

E u r o p e a n

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O r t h o k e r a t o l o g y!

Fitting Protocol!
Case History!
Present status of visual function!
Eye-vision symptoms!
Ocular history!
Medical history!

Pre-fitting Examination!
Unaided and corrected Visual Acuity!
Refraction!
Corneal Topography. Instrumental calibration in necessary!
Biomicroscopy!
E u r o p e a n

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O r t h o k e r a t o l o g y!

Fitting Protocol!
Delivery Care!
Patient has to be given:!

verbal and practical insertion and removal techniques!


verbal, written and practical instructions on cleaning and disinfection procedures!
hygiene instructions: !
antibacterial detergent before manipulating the lenses, !
no use of tap water in rinsing lenses or container, !
replacement of the container

Discuss post-fitting follow-up protocol!


Discuss risks and normal versus abnormal symptoms!

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

Fitting Protocol!
Delivery Care!
Early am in the morning after the first night!
One week!
Two weeks!
Four weeks!
3 Months!
6 Months!
9 months!
12 months!
Every 6 months!

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

Fitting Protocol!
Patient Education!
Discuss the pros and cons of the procedures with the patient!
Discussion includes the following:!
Treatment time is dependent on an individual basis!
Initial treatment may need spectacle wear during the day!
Overnight wear increases risks compared to daily wear lenses!
Perception of halos or flare around lights at night may be experienced!
Treatment includes a number of scheduled and unscheduled visits:!
Scheduled follow-up should be respected to avoid delay of treatment or complications. !
Unscheduled visits are necessary if unexpected complications arise.!

Instructions provided by the practitioner must be followed!


Poor compliance may be risky and lead to complications!
After the treatment has been complete, a follow-up every 6 months is required
to ensure eye health!
Severe complications may need to stop the treatment!
E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

Follow-up
Protocol!

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

Lens Care!

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

Informed Consent!

E u r o p e a n

A c a d e m y

o f

O r t h o k e r a t o l o g y!

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